Leadership Guide
The Purity Paradox
You can't prove what your product is without simultaneously proving what it isn't.
What the Framework Reveals
Why identity and purity testing are really one test wearing two names
5
Critical Quality Attributes that aren't actually independent (Safety, Identity, Sterility, Purity, Potency)
2
categories of impurities every CGT plan must anticipate
1
paradox: confirming identity is what reveals impurities
Identity testing confirms what your therapeutic cell population is. Purity testing measures freedom from everything it isn't. These sound like separate activities — they aren't. The process of confirming identity is what reveals impurities in the first place, which means the path to proving what your product is runs directly through characterizing what it's not. The third in MKA's CGT technical explainer series, this paper breaks down why that interconnection reshapes analytical development, resourcing, and regulatory strategy.
Source: Pages TBD · Jan 2026 · MKA-20B-WP, Executive Summary
Built for: CGT manufacturing quality and analytical development teams.